Scale-Ups & SMEs
For Scale-Ups ans SMEs it is important to be aware of the critical success factors. Many times, there is not just a signle root cause for a specific problem but there are multiple root causes intertwined, which makes it difficult to analyze and solve the situation. It requires a multidisciplinary approach looking at various aspects of the business or company to find the root causes and their interdependencies with the overall value proposition.
A four step approach to build your proposition
We have developed a systematic approach, which helps you to understand exactly where you are in your journey to the MedTech market, where your biggest gaps and your most important next steps are.
For getting a good understanding of potential root causes, MD squared carries out a QuickExam™, a structured way to look at and evaluate the core of the proposition from different angles. The focus and activities during the QuickExam™ are tailored to the root causes and specific questions of the client. A QuickExam™ typically has a 2 to 3 months throughput time, depending on the size and complexity of the proposition or problem.
Depending on the type of problem or request, the following areas of expertise can be offered:
- Product: product definition, intended use and classification
- Clinical data: Clinical Evaluation, Clinical Data collection and Post-Market Clinical Follow-Up
- Regulatory: Regulatory requirements and applicable standards (MDR/IVDR, FDA and SFDA)
- Quality: Risk based Quality Management System according ISO13485:2016
- Technology Development and Manufacturing: Technical Documentation, Adequate Product Design and Validation
- Market: Addressable market and barriers, Standard of Care and treatment alternatives
- Business Strategy: viability of business case
It is important that areas line up equally during development of a product and any gaps are timely identified and filled in.
For relevant segments, the level of maturity is defined, showing the gaps to reach compliance with the requirements and identify the necessary steps to take to improve the situation.
Key reasons for limited growth
Sales stagnates after launch
At launch, new products and applications get some traction in the market, but sales stagnates quickly and unexpected. There can be multiple reasons. For example: early adapters that have bought the product, are not a good reflection of the main stream customers in the markets.
Entering new markets with their own specific regulations takes much more time and effort, usually asking for specific knowledge that is not available.
Market share of existing product decreases
It can happen that market shares of existing products decrease for unclear reasons. The only way to find out what is going on, is to analyse in a structured way what is going on. Root causes can be multple, related to e.g. sales employees, product, customer. Apply an integral view and approach is key.
Reimbursement takes too long
Getting reimbursement is a strong accelerator for the business. However, it takes a long time before this is established with no guarantee upfront. And usually there is no backup scenario available.
Running out of cash
In many companies, cash projections are too optimistic with hardly any safety buffers. Developments of new medical devices often take much longer than expected and require higher investments than originally budgeted. Attracting funding takes a lot of time and effort.